NCT07366905

Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block

Clinical Observation of Bupivacaine Liposome for Lower Extremity Femoral Nerve Block

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hainan Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This prospective, sequential dose-finding clinical observational study aims to estimate the median effective concentration (EC50) and the 95% effective concentration (EC95) of liposomal bupivacaine for ultrasound-guided femoral nerve block. Sensory and motor block endpoints are evaluated separately at 30 minutes after block placement using a modified up-and-down (sequential allocation) design, with trial termination after eight reversal points.

Detailed description

This prospective clinical observational, sequential dose-finding study is designed to determine the effective concentrations of liposomal bupivacaine for ultrasound-guided femoral nerve block in patients undergoing lower limb surgery or related procedures. All patients receive ultrasound-guided femoral nerve block performed by an experienced anesthesiologist using a standardized technique. A fixed injection volume of liposomal bupivacaine is administered, while the drug concentration is adjusted according to a modified up-and-down sequential method. The concentration for each subsequent participant is determined based on the response of the preceding participant. Following a positive response, the concentration is decreased; following a negative response, the concentration is increased by a pre-specified step size. The study is terminated after eight reversal points (crossovers) are observed. To independently characterize sensory and motor block dose-response relationships, participants are allocated into two endpoint-specific observation groups: Sensory block group Sensory function in the femoral nerve distribution is assessed 30 minutes after block placement using standardized sensory testing. Complete loss of sensation at 30 minutes is defined as a positive response, while preserved sensation is defined as a negative response. Motor block group Motor function of the quadriceps muscle is evaluated 30 minutes after block placement using a standardized motor strength assessment. Complete loss of quadriceps muscle strength or paralysis at 30 minutes is defined as a positive response, while preservation of motor function is defined as a negative response. The primary objective of this study is to estimate the EC50 and EC95 of liposomal bupivacaine for: femoral nerve sensory blockade, and femoral nerve motor blockade, based on sequential allocation data and appropriate dose-response modeling. Secondary objectives include describing the differential sensory-motor block profile of liposomal bupivacaine and evaluating its clinical feasibility and safety for femoral nerve block applications. All patients are monitored for block-related adverse events, including signs of local anesthetic systemic toxicity, nerve injury, and other complications throughout the perioperative period.

Conditions

• Patients Eligible for Elective Lower Extremity Femoral Nerve Surgery
• Knee Arthroscopic Surgery

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine, 266mg	Liposomal bupivacaine administered for ultrasound-guided femoral nerve block at varying concentrations using a modified up-and-down sequential dose-finding design.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China